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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0009027 | Other Identifier | Korea National Institute of Health |
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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Sinchon Severance Hospital, Yonsei University College of Medicine |
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The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment.
Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation.
Participants will:
There have been reports that early rhythm control therapy reduces various heart events in patients with atrial fibrillation. The definition of "early" atrial fibrillation defined in this study was defined as a patient within one year of diagnosis. This means clinical atrial fibrillation diagnosed by 12-lead electrocardiogram.
Atrial high rate episode (AHRE) may be found through various Cardiac Electronic Implantable Devices (CIED), which is defined as subclinical atrial fibrillation. There have been many studies on the risk of such subclinical atrial fibrillation causing cerebral infarction, and meta-analysis results show that there is a high risk of thromboembolism if there is an episode of 30 seconds or the sum of duration is more than 24 hours. However, there is no research on the rhythm control therapy for patients with subclinical atrial fibrillation, and this study might be considered as an important factor in determining the truly early atrial fibrillation treatment guideline. Therefore, this study aims to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
This study is a randomized, multicenter, prospective, interventional study to observe the efficacy of early rhythm control treatment compared to general control treatment in patients with subclinical atrial fibrillation. According to the electronic random assignment program, it is divided into two groups (early rhythm control group, general control group) and allocated at a 1:1 ratio. This study is open-label study. Early rhythm control groups get rhythm control treatment for atrial fibrillation based on guidelines. This includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management (observation, heart rate control treatment if necessary) without the above atrial fibrillation rhythm control treatment. In both groups, appropriate anticoagulant treatment is given if there is an indication of cerebral infarction prevention associated with atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early rhythm control group | Experimental | Early rhythm control group receives atrial fibrillation rhythm control treatment based on guidelines. This includes antiarrhythmic treatment, cardioversion, and catheter ablation. Antiarrhythmic drugs include flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on, and the doctor chooses the drug in consideration of structural heart disease, coronary artery disease, abnormal left ventricular hypertrophy, and heart failure.(Refer to the Korean Heart rhythm Society atrial Fibrillation Treatment Guidelines) Catheter ablation is a procedure that uses high-frequency energy to block the site of tachycardia in the heart. Cardioversion is a procedure that converts the electrical activity of the heart to sinus rhythm by directly giving electric shock on the surface of the heart. Catheter ablation or cardioversion is a treatment method performed only when clinical atrial fibrillation is confirmed. |
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| general control group | Active Comparator | The general control group receives general management without the above atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early rhythm control group | Drug | flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on |
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| Measure | Description | Time Frame |
|---|---|---|
| Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate) | Recurrence is defined as
Kaplan-Meier survival analysis will be performed, and the Log-rank test will be used to compare the groups. A Cox proportional-hazards model will be performed, including the experimental group and the randomization stratification factor. The hazard ratio and its 95% confidence interval between the two groups will be presented. Statistical significance will be determined by a P-value of < 0.05. | From enrollment to 1 year |
| side effects related to medication or other treatments | From enrollment to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation effect on quality-of-life questionnaire score | Atrial fibrillation effect on quality-of-life questionnaire scale 0 to 100 Score ranges from a minimum of 0 to a maximum of 100. A higher score indicates a worse outcome. | From enrollment to 1 year |
| cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation |
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Inclusion Criteria:
However, enrollment is possible even if it includes one of the following two cases ⓐ Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring
ⓑ If there is a record of atrial fibrillation, but Paroxysmal AF less than 30 seconds
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ju Youn Kim, Clinical assistant professor, MD, Ph.D | Contact | 82-2-3410-3419 | kzzoo921@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34755543 | Result | Sagris D, Georgiopoulos G, Pateras K, Perlepe K, Korompoki E, Milionis H, Tsiachris D, Chan C, Lip GYH, Ntaios G. Atrial High-Rate Episode Duration Thresholds and Thromboembolic Risk: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2021 Nov 16;10(22):e022487. doi: 10.1161/JAHA.121.022487. Epub 2021 Nov 10. | |
| 32860505 | Result |
| Label | URL |
|---|---|
| 2021 KHRS Guideline of Atrial Fibrillation Management | View source |
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| UNKNOWN |
| Wonju Severance Christian Hospital | OTHER |
| Asan Medical Center | OTHER |
| Inje University Ilsan Paik Hospital | OTHER |
| The Catholic University of Korea | OTHER |
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| cardioversion, catheter ablation | Procedure | only when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed |
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| general control | Other | General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription. |
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Individual events and composite events will be presented using frequencies and percentages. Cox proportional-hazards model will be performed, including the treatment group and the randomization stratification factor. The Log-rank test will be used to compare the incidence rates and hazard ratios between the experimental and active comparator groups. |
| From enrollment to 1 year |
| NTproBNP(pg/ml) | Measured in pg/mL | From enrollment to 1year |
| Korean Montreal Cognitive Assessment (K-MoCA) | Korean Montreal Cognitive Assessment (K-MoCA) score 0 to 30. Score ranges from a minimum of 0 to a maximum of 30, where higher scores indicate better cognitive performance. | From enrollment to 1 year |
| Left ventricular ejection fraction(LVEF) | LVEF in percentage as measured by echocardiography | From enrollment to 1 year |
| Diastolic function assessment | Calculate the E/e' ratio using the early diastolic filling velocity (E) and the early diastolic mitral annular velocity (e'), both measured in m/s. | From enrollment to 1year |
| Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available. |
| 32865375 | Result | Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004554 | Electric Countershock |
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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